Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study

Seborrheic Keratosis Clinical Trial

Official title:

Evaluation of Nano-Pulse Stimulation (NPS) in Patients With Seborrheic Keratosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03846531
• Other study ID #: NP-SK-002
• Status: Completed
• Phase: N/A
• Start date: May 4, 2017
• Est. completion date: May 22, 2018

Study information

• Verified date: July 2023
• Source: Pulse Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this trial is to evaluate Nano-Pulse Stimulation (NPS) to clear or remove Seborrheic Keratosis (SK) lesions from off-facial areas of healthy adult subjects.

Description:

Evaluate Nano-Pulse Stimulation (NPS) to clear or remove Seborrheic Keratosis (SK) lesions from off-facial areas of healthy adult subjects. The specific objectives of this study are to: - Document the non-treated appearance of off-face SKs. - Evaluate the clearance of SKs in off-face locations post-treatment versus pre-treated appearance of the same lesion. - Evaluate the clearance of the treated SKs at various points in time over several weeks following the initial procedure, compared to the pre-treated SKs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 22, 2018
• Est. primary completion date: November 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Willing to sign the informed consent
• Has a clinical diagnosis of stable, clinically typical seborrheic keratosis
• Medically determined candidate for at least 4 off-face SK lesions
• Must have at least four treatable SK lesions and be willing to have NPS treatment on any three of the four treatable SK lesions. Treatable SK lesions must: be at least 1 mm in height, and no greater than 3 mm in height and not have a dimension perpendicular to the longest dimension of greater than 7.5mm or longer in any dimension than 20mm
• Willing to have three of the designated SK lesions treated in a single treatment session
• Willing to return to the PI's office for five additional study visits at specified intervals over 106-days
• Agrees to high resolution photos of both the treated SK lesions and the untreated SK lesion
• No subject identity will be possible via the "lesion-only" photograph
• No evidence of active infection in the designated tissue prior to treatment
• Is not allergic to Lidocaine or Lidocaine-like products
• Not pregnant or lactating

Exclusion Criteria:

• Has an implantable electronic device (e.g., automatic defibrillator)
• Active infection or history of infection within 90 previous days in designated test area
• Not willing or able to sign the Informed Consent
• Non-English speaking or reading
• Is known to be immune-compromised
• Known to be a keloid producer
• On blood thinning medications
• Diseases, conditions, or situations wherein the PI judges that the patient is not appropriate for participation in the study

Related Conditions & MeSH terms

• Keratosis
• Keratosis, Actinic
• Keratosis, Seborrheic
• Lesion Skin
• Seborrheic Keratosis

Intervention

Device:
• Nano-Pulse Stimulation (NPS)
The Pulse generator delivers electrical pulses (nanosecond duration) that are applied directly to targeted lesion using sterile treatment tips with micro-needles.

Locations

Country	Name	City	State
United States	Laser & Dermatologic Surgery Center	Chesterfield	Missouri
United States	Skin Care Physicians	Chestnut Hill	Massachusetts
United States	Zel Skin & Laser Specialists	Edina	Minnesota
United States	Premier Plastic Surgery	San Mateo	California

Sponsors (1)

Lead Sponsor	Collaborator
Pulse Biosciences, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hruza GJ, Zelickson BD, Selim MM, Rohrer TE, Newman J, Park H, Jauregui L, Nuccitelli R, Knape WA, Ebbers E, Uecker D. Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Seborrheic Keratoses. Dermatol Surg. 2020 Sep;46(9):1183-1189. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clearance of SK Lesions	Total Number of treated SK lesions per participant rated as clear or mostly-clear by the Principal Investigator at each clinical site.	106-day post-treatment